The effect of new oral anticoagulants and extended thromboprophylaxis policy on hip and knee arthroplasty outcomes: observational study (original) (raw)
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Acta Orthopaedica
Background and purpose: There are concerns that bleeding following primary total hip arthroplasty (THA) contributes to prolonged wound drainage and prosthetic joint infection (PJI). We examined whether short (1–5 days), medium (6–14 days), and extended (≥ 15 days) duration of thromboprophylaxis is associated with the 5-year revision rate after THA due to osteoarthritis.Patients and methods: We performed a cohort study based on data from hip arthroplasty and administrative registries in Denmark and Norway (2008–2014). The outcome was revision surgery due to PJI, aseptic loosening or any cause, and patient mortality. Adjusted cause-specific hazard ratios (HRs) were analyzed with Cox regression analyses.Results: Among 50,482 THA patients, 8,333 received short, 17,009 received medium, and 25,140 received extended thromboprophylaxis. The HRs for revision due to PJI within 5 years were 1.0 (95%CI 0.7–1.3) and 1.1 (CI 0.9–1.3) for short and extended vs. medium treatment, whereas HR for ext...
Clinical Orthopaedics & Related Research, 2019
Background Although the use of thromboprophylaxis is well established, there is no consensus on the preferred thromboprophylaxis regimen after THA; large, population-based studies offer an opportunity to examine this problem in a robust way that can complement results from randomized trials. Questions/purposes Using data from a large national registry, we asked: (1) Is there any difference between low-molecular weight heparin (LMWH) and new oral anticoagulants in preventing symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), after One of the authors certifies that he (OR) has received personal fees during the study period, in an amount of less than USD 10,000, from Zimmer Biomet (Winterthur, Switzerland) as reimbursement for presentation (Gothenburg, Sweden), outside the submitted work. One of the authors certifies that he (MM) has received personal fees during the study period, in an amount of less than USD 10,000, from Zimmer Biomet (Winterthur, Switzerland) as reimbursement for presentation (Copenhagen, Denmark); and grants as institutional support in an amount of less than 10,000 USD, from Link (Hamburg, Germany), all outside the submitted work. Clinical Orthopaedics and Related Research® neither advocates nor endorses the use of any treatment, drug, or device. Readers are encouraged to always seek additional information, including FDA approval status, of any drug or device before clinical use. Each author certifies that his institution approved the human protocol for this investigation and that all investigations were conducted in conformity with ethical principles of research. This study was performed in Sweden as a nationwide study, based on national registries with continuous data collection from all performing centers in the country. The authors in their respective centers in Gothenburg and Stockholm, Sweden performed the analysis and writing.
Thrombosis research, 2012
BACKGROUND: The American College of Chest Physicians (ACCP) guidelines recommends thromboprophylaxis for total hip replacement (THR) and total knee replacement (TKR) patients. We examined alignment with ACCP thromboprophylaxis guidelines among THR/TKR patients, and compared symptomatic venous thromboembolism (VTE), bleeding event rates and risk factors for VTE between patients receiving ACCP-recommended thromboprophylaxis ('ACCP') and those who did not ('non-ACCP'). METHODS: This retrospective observational study used a large US health plan claims database that was linked to an inpatient database containing detailed inpatient medication use and a database containing date-of-death information. Patients who had THR/TKR surgery between April 01, 2004 and December 31, 2006 were included. Comparisons of VTE and bleeding events between ACCP and non-ACCP patients were analyzed using chi-squared tests and multivariate logistic regression. RESULTS: Of 3,497 linked patient...
Orthopaedics & Traumatology: Surgery & Research, 2020
Introduction: Prevention of venous thromboembolism (VTE) generally consists of low molecular weight heparin (LMWH) or direct oral anticoagulants (DOACs) after total hip arthroplasty (THA) or total knee arthroplasty (TKA). Enhanced recovery after surgery (ERAS) protocols may reduce the VTE risk after these procedures. The aim of this study was to compare the risk of VTE and the risk of bleeding complications in a non-selected population of primary THA and TKA cases done within an ERAS protocol. Hypothesis: The risk of postoperative VTE after primary THA and TKA is lower than the risk of bleeding complications within an ERAS protocol. Methods: This was a prospective observational study conducted on a national scale in France. All patients who underwent primary unilateral THA or TKA at one of 11 participating hospitals between October 2016 and October 2017 were enrolled and followed for 3 months. The occurrence of a VTE or major bleeding event was recorded. No patients were lost to follow-up at 3 months. Results: Of the 1110 THA cases, there were 5 VTE (0.4%) and 19 bleeding events (1.7%). Of the 893 TKA cases, there were 9 VTE (1.0%) and 14 bleeding events (1.7%). There was no significant difference in the VTE incidence and bleeding event incidence after THA and TKA. The overall incidence of bleeding complications (1.7%) was significantly greater than the overall incidence of VTE complications (0.7%) (p = 0.005). This was the case after THA (p = 0.004) but not after TKA. Discussion: The primary finding of this study is that bleeding complications are significantly more common than VTE complications after THA or TKA within an ERAS protocol. Based on these findings, the cost-benefit ratio of antithrombotic prophylaxis by LMWH or DOACs in this context should be reassessed. Level of evidence: IV; Prospective cohort study without control group.
PLOS ONE, 2021
Objective To search, review, and analyze the efficacy and safety of various anticoagulants from randomized clinical trials (RCTs) of anticoagulants for THA and TKA. Design PRISMA-compliant Bayesian Network Meta-analysis. Data sources and study selection The databases of The Medline, Embase, ClinicalTrial, and Cochrane Library databases were searched until March 2017 for RCTs of patients undergoing a THA or TKA. Main outcomes and measures The primary efficacy measurement was the venous thromboembolism Odds ratio (OR). The safety measurement was the odds ratio of major or clinically relevant bleeding. OR with 95% credibility intervals (95%CrIs) were calculated. Findings were interpreted as associations when the 95%CrIs excluded the null value. Results Thirty-five RCTs (53787 patients; mean age range, mostly 55–70 years; mean weight range, mostly 55–90 kg; and a higher mean proportion of women than men, around 60%) included the following Anticoagulants categories: fondaparinux, edoxaba...
Arthroplasty
Background Guidelines support aspirin thromboprophylaxis for primary total hip and knee arthroplasty (THA and TKA) but supporting evidence has come from high volume centers and the practice remains controversial. Methods We studied 4562 Medicare patients who underwent elective primary THA (1736, 38.1%) or TKA (2826, 61.9%) at 9 diverse hospitals. Thirty-day claims data were combined with data from the health system’s electronic medical records to compare rates of venous thromboembolism (VTE) between patients who received prophylaxis with: (1) aspirin alone (47.3%), (2) a single, potent anticoagulant (29%), (3) antiplatelet agents other than aspirin or multiple anticoagulants (21.5%), or (4) low-dose subcutaneous unfractionated heparin or no anticoagulation (2.2%). Sub-analyses separately evaluating THA, TKA and cases from lower volume hospitals (n = 975) were performed. Results The 30-day VTE incidence was 0.6% (29/4562). VTE rates were equal in patients receiving aspirin and those ...
Oral thromboprophylaxis following total hip replacement: the issue of compliance
Orthopaedics & traumatology, surgery & research : OTSR, 2012
Thirty-five to 40 days' thromboprophylaxis is recommended following total hip replacement (THR). Low molecular weight heparin (LMWH) injected by a health professional ensures good compliance. Compliance with recent oral anticoagulants has not been precisely assessed. Oral self-administration, without coagulation monitoring tests, may be a worrying issue in the management of what is a potentially catastrophic adverse event, without prodromal symptoms alerting the patient to the need for regular intake throughout the prescription period. It was hypothesized that compliance with these new oral anticoagulants is good over the entire treatment period. The present cohort study prospectively assessed compliance with oral medication (two capsules of dabigatran etexilate [Pradaxa(®)] per day in a single dose at a set time) following THR. An electronic device continuously monitored the day and time of extraction of capsules from the package. All included patients underwent clinical and ec...